Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with Myelodysplasia or Myeloproliferative Disorders. During the course of this study, we will attempt to learn whether a particular type of blood cell, called a Cytokine Induced Killer (CIK) cell may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.

Patients with advanced MDS must have < 10% marrow blasts prior to receiving conditioning with TLI/ATG. Less than 10% marrow blasts must be documented by marrow examination within 1 month of starting conditioning. If necessary, a cytoreductive regimen will be determined by referring centers.

Patients with evolution to AML are required to be in a morphologic leukemia free-state with blasts <5% (50).

Myeloproliferative Disorders

B) Myeloproliferative disorders to be included:

Idiopathic Myelofibrosis

Polycythemia vera

Essential Thrombocythemia

Chronic Myelomonocytic Leukemia

Chronic Neutrophilic Leukemia

Chronic Eosinophilic Leukemia

Philadelphia chromosome-negative CML.

Hypereosinophilic Syndrome

Systemic Mastocytosis

Patients with MPD must have < 10% marrow blasts prior to receiving conditioning with TLI/ATG. Less than 10% marrow blasts must be documented by marrow examination within 1 month of starting conditioning. If necessary, a cytoreductive regimen will be determined by referring centers.

Patients with evolution to AML are required to be in a morphologic leukemia-free state less than 5% in a marrow aspirate. Presence of residual dysplastic features following cytoreductive therapy is acceptable.

Therapy-related myeloid neoplasms

Patients with t-MDS must have < 10% marrow blasts prior to receiving conditioning with TLI/ATG. Less than 10% marrow blasts must be documented by marrow examination within 1 month of starting conditioning. If necessary, a cytoreductive regimen will be determined by referring centers.

Patients with t-AML are required to be in a morphologic leukemia free-state with blasts <5%.

2. Patient age > 50 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants.

3. A fully HLA matched or single antigen/allele mismatched sibling or unrelated donor is available.

Viral infections: HIV positive patients are not eligible for this protocol. Hepatitis B and C positive patients will be evaluated on a case-by-case basis

Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible. Patients with a prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible.

Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers.

HIV seropositivity

4.2.3 Unrelated Donor Inclusion Criteria

Donors must be HLA-matched or one allele or antigen mismatched.

Donor must consent to PBSC mobilization with G-CSF and apheresis as well as collection and donation of plasma. Bone marrow unrelated donors are not eligible for this protocol.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392989